(51 days)
The Model PMT850 is indicated for adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue.
The Model PMT850 device is a pulsed shortwave diathermy device. The Model PMT850 system consists of a Generating Unit connected by a cable to the Treatment Applicator. The Treatment Applicator and cable are a single unit which is connected or disconnected easily from the Generating Unit. The Generating Unit connects to a standard AC electrical outlet by a grounded 3-prong UL/CSA approved, medically rated electric cord.
Treatment with the Model PMT850 requires placing the Treatment Applicator on top of any standard dressing over the area to be treated, setting the dials on the Generating Unit, and turning the device on. There are 6 possible pulse frequency and 6 possible power control settings on the generating unit of the Model PMT850, providing 36 setting options for treatment. Suggested treatment settings are discussed in the Operating Manual for the Model PMT850.
This document describes a 510(k) premarket notification for the Model PMT850, a nonthermal shortwave therapy (SWT) device. The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device, K903675, MRT sofPulse shortwave diathermy. This equivalence is based on similar intended use, indications for use, and technological characteristics, and confirmed through performance studies.
| Characteristic / Acceptance Criteria | Reported Device Performance (Model PMT850) |
|---|---|
| Intended Use | Same as predicate: palliative treatment of postoperative edema and pain in superficial soft tissue. |
| Indications for Use | Same as predicate: palliative treatment of postoperative edema and pain in superficial soft tissue. |
| Technological Characteristics | Equivalent to predicate (power supply, operating principle, energy transfer mechanism, treatment applicator, device physical conformation, packaging, operating frequency, RF output impedance, RF pulse width, RF pulse waveform, pulse frequency, pulse duty cycle, exposure timer). The PMT850 requires lower peak RF generator power for equivalent peak power from the applicator. |
| Applicator Field Measurements | Results support substantial equivalence with the predicate device. |
| Output Energy Comparison | Results support substantial equivalence with the predicate device. |
| Conformance to Electrical Safety Standards (e.g., UL 60601-1) | Will comply prior to marketing. |
| Conformance to Electromagnetic Compatibility Standards (e.g., IEC 60601-1-2) | Will comply prior to marketing. |
| Biocompatibility Testing of Treatment Applicator Covering | Passed tests for cytotoxicity/irritancy (ISO 10993-5) for its high-grade polyethylene foam (device itself does not contact patient skin). |
Note: The document explicitly states, "The only technical specification that differs is the lower peak RF generator power required for the Model PMT850 Generating Unit to provide an equivalent amount of Peak Power as the predicate from the Treatment Applicator for each of the six power settings." This difference is deemed not to affect safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing (Applicator Field Measurements and Output Energy Comparison). It mentions that the testing was conducted by two independent laboratories. The data provenance is implied to be from these laboratory tests, likely conducted in the United States (given the FDA submission and the sponsor's location in Arizona). The studies were likely prospective in nature, as they involve testing a new device against a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The "ground truth" here would relate to the objective measurements of device performance, which were conducted by independent laboratories. The document does not specify the qualifications of the personnel performing these tests.
4. Adjudication Method for the Test Set
This type of adjudication method (e.g., 2+1, 3+1) is typically associated with expert review of medical images or clinical outcomes for diagnosis, prognosis, or treatment effect studies. For the engineering performance tests described (Applicator Field Measurements, Output Energy Comparison), an adjudication method is not applicable as the results are quantitative measurements against predefined specifications or comparison with a predicate. The document states testing was done by "two independent laboratories," suggesting independent verification rather than expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical therapy device, not an AI-powered diagnostic or interpretive tool that would require human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of a device without human input, which could be considered analogous to the "performance studies" (Applicator Field Measurements and Output Energy Comparison) conducted. These tests were evaluating the intrinsic performance characteristics of the Model PMT850 itself and its comparison to the predicate, making it a form of standalone performance assessment in an engineering context. However, it's not an "algorithm" in the sense of AI.
7. The Type of Ground Truth Used
The ground truth used for these performance studies was the established technical specifications and measured output of the legally marketed predicate device (MRT sofPulse shortwave diathermy). The Model PMT850's performance was compared to this benchmark to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
There is no training set in the context of this device. A training set is relevant for machine learning algorithms. This submission pertains to a physical medical device demonstrating equivalence based on engineering specifications and direct performance comparisons.
9. How the Ground Truth for the Training Set was Established
As there is no training set for this device, this question is not applicable.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.